Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
Collecte de données
Maladies du sein+6
+ Néoplasmes du sein
+ Métastase lymphatique
Étude diagnostique
Résumé
Date de début de l'étude : 1 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node status after neoadjuvant therapy in women with stage II, III, or IV breast cancer. * Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients. OUTLINE: This is a pilot study. After neoadjuvant chemotherapy, patients undergo sentinel lymph node (SLN) mapping comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify the SLN. Within 1-2 hours after injection, patients undergo SLN biopsy followed immediately by definitive local surgery comprising modified radical mastectomy or breast segmentectomy with axillary lymph node dissection. SLN and axillary lymph nodes are examined by hematoxylin and eosin (H \& E) staining for the presence or absence of metastases. If the lymph nodes are negative for tumor by H \& E, the lymph nodes are further analyzed by immunohistochemistry. The primary tumor is analyzed by microarray analysis for gene expression profile determinations. Patients are followed at 2-3 weeks after surgery. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed carcinoma of the breast * Stage II, III, or IV infiltrating disease * Unilateral or bilateral AND unifocal or multifocal disease * Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal therapy, and/or biologic therapy) AND had any of the following responses: * Clinical complete response, partial response, no change, or disease progression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Hemoglobin \> 7.0 g/dL * Platelet count \> 50,000/mm\^3 * WBC \> 2,000/mm\^3 Hepatic * PT and PTT \< 1.5 times normal Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * No prior definitive breast radiotherapy to the target breast Surgery * No prior axillary surgery on the side of the sentinel lymph node Other * More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission tomography scan, or MUGA scan)
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, United StatesVoir le site